Cumulative Dose-Response Study of Non-CFC Propellant HFA 134a Salbutamol Sulfate Metered-Dose Inhaler in Patients With Asthma

Kleerup, Eric C.; Tashkin, Donald P.; Cline, Ann; Ekholm, Bruce P.

doi:10.1378/chest.109.3.702

Cited by 58 publications

(15 citation statements)

References 11 publications

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“…Compared with CFC salbutamol, the HFA pMDI spray looks different mainly because of the reduced jetting velocity, sounds different for the same reason, and tastes different, largely due to the ethanol, which has recently been reported to cause a transient increase in breath alcohol levels (7). Clinically, the effects and incidence of side effects are similar as has been demonstrated in a number of clinical trials (8)(9)(10)(11).…”

Section: Figure 1) Packaging Of Inhalant Therapies In Canada For the supporting

confidence: 68%

New Delivery Systems and Propellants

Dolovich

1999

Canadian Respiratory Journal

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The removal of chlorofluorocarbon (CFC) propellants from industrial and household products has been agreed to by over 165 countires of which more than 135 are developing countries. The timetable for this process is outlined in the Montreal Protocol on Substances that Deplete the Ozone Layer document and in several subsequent amendments. Pressured metered dose inhalers (pMDIs) for medical use have been granted temporary exemptions until replacement formulations, providing the same medication via the same route, and with the same efficacy and safety profiles, are approved for human use. Hydrofluoroalkanes (HFAs) are the alternative propellants for CFCs-12 and -114. Their potential for damage to the ozone layer is nonexistent, and while they are greenhouse gases, their global warming potential is a fraction (one-tenth) of that of CFCs. Replacement formulations for almost all inhalant respiratory medications have been or are being produced and tested; in Canada, it is anticipated that the transition to these HFA or CFC-free pMDIs will be complete by the year 2005. Initially, an HFA pMDI was to be equivalent to the CFC pMDI being replaced, in terms of aerosol properties and effective clinical dose. However, this will not necessarily be the situation, particularly for some corticosteroid products. Currently, only one CFC-free formulation is available in Canada -Airomir, a HFA salbutamol pMDI. This paper discusses the in vitro aerosol characteristics, in vivo deposition and clinical data for several HFA pMDIs for which there are data available in the literature. Alternative delivery systems to the pMDI, namely, dry powder inhalers and nebulizers, are briefly reviewed. sont des gaz à effet de serre, leur potentiel global de réchauffement repré-sente une fraction (un dixième) de celui des CFC. Des formules de substitution pour presque tous les médicaments respiratoires administrés par inhalation ont été et sont testées. Au Canada, on espère que la transition vers ces aérosols-doseurs générés aux HFA ou ne contenant pas de CFC sera terminée vers 2005. Initialement, un aérosol-doseur généré par HFA devait être équivalent à l'aéro-sol-doseur généré par CFC que l'on remplaçait, relativement aux propriétés de l'aérosol et à la dose clinique efficace. Cependant, ce ne sera pas nécessairement le cas, en particulier pour certains produits contenant des corticostéroïdes. Actuellement, une seule formulation sans CFC est disponible au Canada -Airomir, un aérosol-doseur contenant du salbutamol et généré par HFA. Le présent article discute des caractéristiques de l'aérosol in vitro et du dépôt in vivo, et des données cliniques obtenues sur plusieurs aérosols-doseurs générés par HFA et sur lesquels des données sont disponibles dans la littérature. L'alternative aux aérosols-doseurs, à savoir, les inhalateurs à poudre sèche et les nébuliseurs, sont brièvement passés en revue.

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Section: Figure 1) Packaging Of Inhalant Therapies In Canada For the supporting

confidence: 68%

New Delivery Systems and Propellants

Dolovich

1999

Canadian Respiratory Journal

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“…Hendeles et al [12] observed the same effects on central nervous system, gastrointestinal, heart and others systems during safety and efficacy comparison between hydrofluoroalkane salbutamol approved by FDA and CFC containing salbutamol which was intended to replace. This is unlikely to be the result of an increased availability of salbutamol since clinical studies have shown that the adverse event profiles of Azmasol inhaler and Vento-lin Evohaler are the same [3][4][5][6][7].…”

Section: Discussionmentioning

confidence: 99%

“…A post-marketing surveillance is conducted in broadly based clinical settings contributes to the evaluation of drug safety. Controlled trials had shown that metered dose salbutamol inhalers using hydrofluoroalkane were comparable in terms of efficacy and safety to existing salbutamol inhalers using chlorofluorocarbon as the propellant [3][4][5][6][7]. Accordingly the post-market surveillance strategy ensures the benefits of using a drug without any risk.…”

Section: Introductionmentioning

confidence: 99%

Comparative toxicity assessment between generic salbutamol sulphate inhaler containing hydrofluoroalkane and Ventolin Evohaler

Roy¹,

Jalil²,

Tithi³

et al. 2013

OJPM

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Salbutamol is a short-acting β 2 -adrenergic receptor agonist used for the relief of bronchospasm such as asthma and chronic obstructive pulmonary disease (COPD). It is mostly taken through an inhaler device. The comparative toxicity assessment between two salbutamol sulfate preparations containing hydrofluoroalkane (HFA) metered dose inhalers with 100 μg per puff was evaluated in selected patients with asthma and COPD after prescribing. An open label, non-randomized, non-interventional observational study was designed. A large cohort of patients with asthma or related respiratory disorder of the general population from Dhaka and Chittagong of Bangladesh were recruited and treated with prescribed generic preparation Azmasol inhaler and brand preparation Ventolin Evohaler. Total 508 patients with asthma and minor obstructive airway disease were selected by the general medical practitioners in Bangladesh those who visited out patient consultation center in hospitals and physicians' chambers and reported any adverse side effects of inhaled medications. There were no significant differences between the metered dose generic preparation Azmasol inhaler and Ventolon Evohaler among the patients treated with the medicines in asthma and related respiratory diseases in terms of adverse effects like immune system problem, dizziness, tremor, headache, nervousness, diarrhea, nausea, vomiting, heartburn, palpitation, skin rash, hypertension and taste feeling. It is concluded that Azmasol Inhaler, the generic salbutamol sulphate metered dose preparation containing HFA was as safe as the Ventolin Evohaler, a salbutamol sulfate brand preparation containing HFA when given to the patients in primary care after their physicians' visits. Both the preparations have shown the similar safety profiles after regular use.

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“…This is due to formulation changes and the required redesign of the valve and actuator in order to provide the same dose delivery as the chlorofl uorocarbon (CFC) pMDI [12]. Some clinical trials conducted using bronchodilators [13][14][15][16] and corticosteroids [17][18][19] have shown equivalent response and safety profi le of HFA-pMDI to CFC-pMDI. Although the initial design of the HFA-pMDI was to deliver the same drug dose as the old CFC-pMDIs recent large retrospective cohort studies have since shown that the HFA-pMDI containing corticosteroids provides effi cacy and safety at roughly half the dose compared to CFC-pMDI [20][21][22].…”

Section: Benefi Ts Of Hfa (Cfc-free) Inhaler Devicesmentioning

confidence: 99%